NCT02155998 - Non-Interventional Study PREVENT | Crick

Overview

This is a multicentre, non-interventional, prospective study to be carried out in representative medical institutions in order to get the information on administration of postoperative and post-radiation adjuvant androgen deprivation therapy (including "go" / "no go" decision, regimens, dosages and duration) used in locally advanced prostate cancer patients with high and very high risk of recurrence in Russia.

This is a multicentre, non-interventional, prospective study to be carried out in representative medical institutions in order to get the information on administration of postoperative and post-radiation adjuvant androgen deprivation therapy (including "go" / "no go" decision, regimens, dosages and duration) used in locally advanced prostate cancer patients with high and very high risk of recurrence in Russia. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice. It is planned to enrol 200 subjects in up to 30 sites in Russian Federation. The average number of patients per site is planned as 6 - 10; there are no restrictions on minimum and maximum number of subjects per site in this study.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Postoperative or Postradiation Adjuvant Androgen Deprivation Therapy in Locally Advanced Prostate Cancer (High and Very High Risk) Patients

Eligibility

Sex: MALE

Medical Language ↔ Plain English

Inclusion Criteria: 1. The voluntarily given informed consent, confirmed by the Informed Consent Form, properly signed by both the subject and the investigator. 2. Locally advanced stage of PCa (stage T3-T4, Nx-N0, M0: prostate adenocarcinoma with extracapsular invasion (T3a) or invasion to the seminal vesicles (T3b), invasion to adjacent structures (T4) but without lymphatic invasion (N0) nor metastasis (M0)) 3. Prostatectomy or radiotherapy completed within 3 months prior to the study enrolment 4. High (T3a or Gleason score = 8-10 or PCA \>20 ng/ml) and very high (T3b-T4) risk of recurrence 5. Histologically confirmed diagnosis of prostate adenocarcinoma Exclusion Criteria: 1. Patients participating in clinical trials 2. Any medical condition which on the opinion of the investigator may interfere with the patient's participation in the study, e.g. severe non-malignant concomitant disease which can affect life expectancy 3. Evidence of metastatic disease on imaging studies

Locations (14)

Research Site

Balashikha, Russia

Research Site

Belgorod, Russia

Research Site

Izhevsk, Russia

Research Site

Outcomes

Primary Outcomes

Evaluation of adjuvant endocrine therapy: drugs used for androgen deprivation therapy, regimen, dose, duration

Time frame: up to 15 months after LSI

Secondary Outcomes

Data collection of patients characteristics (age, race, co-morbidities, family history of prostate cancer)

Time frame: up to 15 months after LSI

Data collection of disease information ( disease stage - TNM, histology, Gleason score, PSA level, prior prostate cancer surgery/radiotherapy -types, imaging techniques, neoadjuvant and adjuvant therapy(medications by groups, orchidectomy)

Time frame: up to 15 months after LSI

Proportion of patients with double increase in PSA level during 1 year follow-up